Kornimate/medical-research-clean huggingface dataset:
immune checkpoint inhibitors monitoring of adverse drug reaction

Conditions: Arthritis; Cancer; Cardiac Disease; Endocrine System Diseases; Autoimmune Diseases; Ophthalmopathy; Myositis; Neuropathy

Summary: immune checkpoint inhibitors (icis) might have high grade immune-related adverse events (iraes) from rhumatologic, endocrinologic, cardiac or other system origin. this study investigates reports of drug induced iraes with treatment including anti-pd1, anti-pdl-1, and anti-ctla4 classes using the world health organization (who) database vigibase and the french database base nationale de pharmacovigilance (bnpv).

immune checkpoint inhibitors (icis) have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. however, immune-related adverse events (iraes) can occur. here the investigators use vigibase (http://www.vigiaccess.org/), the world health organization (who) database of individual safety case reports, and in the base nationale de pharmacovigilance (bnpv) which is the french pharmacovigilance database, to identify cases of adverse drug reaction including arthiritis, auto-immune induced diseases, cardiac diseases, endocrinologic diseases, following treatment with icis.

Eligibility criteria:
inclusion criteria: * case reported in the world health organization (who) database and base nationale de pharmacovigilance (bnpv) of individual safety case reports to 01/05/2018 * adverse events reported * patients treated with icis, in monotherapy or combination, included in the atc: ipilimumab (l01xc11), nivolumab (l01xc17), pembrolizumab (l01xc18), durvalumab (l01xc28), avelumab (l01xc31), atezolizumab (l01xc32). exclusion criteria: • chronology not compatible between the drug and the toxicity

Keywords: anti-pd-1 anti-pd-l1 anti-ctla-4 immune checkpoint inhibitors immune adverse drug reactions
cognitive behavioral therapy and the nicotine transdermal patch for cannabis dependence and nicotine dependence

Conditions: Cannabis Dependence; Nicotine Dependence

Summary: the investigators are conducting a stage 1 pilot feasibility study at mclean hospital to develop and refine a cognitive behavioral therapy (cbt) intervention. the investigators aim to develop a feasible 10-week integrated cbt intervention for the treatment of concurrent marijuana dependence and nicotine dependence. the investigators hypothesize that the cbt intervention, in conjunction with nicotine replacement therapy (nrt) in the form of a transdermal nicotine patch, will reduce the use of marijuana and nicotine.

the investigators will conduct a stage 1 pilot feasibility study at mclean hospital to develop and refine a cognitive behavioral therapy (cbt) intervention. twelve subjects (50% female, ages 18-65) who meet diagnostic and statistical manual of mental disorders 4th edition (dsm-iv) criteria for both marijuana and nicotine dependence and seek treatment to stop using both marijuana and tobacco will receive individual cbt aimed at treating both disorders, as well as nicotine replacement therapy (nrt) in the form of a transdermal nicotine patch. subjects will start with a 21-mg nicotine patch for 6 weeks, followed by a taper to a 14-mg nicotine patch for 2 weeks and, finally, a 7-mg nicotine patch for 2 weeks. others will start with a 14-mg patch for 8 weeks followed by a 7-mg patch for 2 weeks. all participants will receive 10 weeks of 1-hour weekly cbt with an experienced clinician. follow-up visits, scheduled at 4, 6, 8, and 10 weeks, will evaluate of the durability of treatment effects on drug use and psychosocial outcomes.

Eligibility criteria:
inclusion criteria: * age range 18-65 years * current dsm-iv cannabis dependence * current dsm-iv nicotine dependence * express a desire to quit cannabis and nicotine use within the next 30 days * daily use of ≥ 10 tobacco cigarettes * for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and additional pregnancy tests at weeks 4 and 8 * expired breath carbon monoxide (co) determination is greater than or equal to 7 ppm over ambient values exclusion criteria: * current diagnosis of other drug or alcohol dependence (other than cannabis or nicotine) * recent (within 3 months) significant cardiac disease * current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type i disorder or significant current suicidal or homicidal thoughts * current use of bupropion * current nrt or other smoking cessation treatment * current cbt or other behavioral treatments for cessation of marijuana or tobacco smoking * current smokeless tobacco use * inability to read or write in english

Keywords: cognitive behavioral therapy nicotine dependence cannabis dependence smoking cessation nicotine replacement therapy
diabetes and sports: evaluation of a diabetes education module

Conditions: Diabetes Mellitus

Summary: this study is a multi-center, randomized prospective trial with a 6-month follow up. a newly developed treatment and education module will be tested compared to a waiting-list control group. the module covers the topic "diabetes and sports". primary outcome variable is diabetes-specific empowerment regarding diabetes and sports. secondary outcome variables are: diabetes-related distress, health-related quality of life, depressive symptoms, self-care behavior, and glycemic control.

the module consists of one lesson (duration: 90 minutes). the module is derived from the empowerment approach and is based on the previously evaluated education and treatment program for type 1 diabetes: primas (nct01220557). the module is designed as a group session held by a trained diabetes educator. patients are randomized either to the immediate participation in the module or to the control group. control group is a waiting-list control group. patients in this waiting-list control group get the education after the completion of the 6-month follow-up.

Eligibility criteria:
inclusion criteria: * intensive insulin treatment * specific interest in "diabetes and sports" * wish to participate in group education * informed consent * fluent in reading and speaking german language exclusion criteria: * diabetes duration \< 4 week * severe organic disease (e.g. terminal renal disease, cancer with poor prognosis) * current treatment of a mental disease * cognitive impairment * dementia * pregnancy

Keywords: diabetes education randomized prospective
light therapy in parkinson's disease

Conditions: Parkinson Disease; Sleep Disorder; Circadian Rhythm Disorders

Summary: the aim of this randomized controlled trial (rct) is to clarify the effect of bright light therapy on motor symptoms and sleep disorders in patients with parkinson's disease.

as the most important biologic rhythm timer, exogenous light supplement has certain benefits for the improvement of sleep quality and dementia. at present, it is gradually used in sleep and neuropsychiatric diseases. in an open study, 120 patients with pd received 4000 to 6000 lux of light, for 60 minutes before habitual bedtime. the patients were followed up for several months to 8 years, and it found the patients who persisted in the treatment improved their mood, anxiety and motor function. clinical studies have confirmed the safety and effectiveness of light in improving insomnia and daytime sleepiness of pd patients. it was found that strong light can significantly improve the patients' motor and non-motor symptoms. however, these findings have not been reported in chinese pd patients. the aim of this randomized controlled trial (rct) is to clarify the effect of bright light therapy on motor symptoms and sleep disorders in patients with parkinson's disease and explore the possible mechanism.

Eligibility criteria:
inclusion criteria: * according to the criteria of pd diagnosis of the mds, pd patients were selected as the research object. the clinical symptoms of pd patients were consistent with hoehn and yahr stages 2-3. * all pd patients have maintained stable drug treatment for at least one month, signed clinical informed consent and agreed not to adjust drugs throughout the light test and follow-up period. exclusion criteria: * using hypnotic or stimulating drugs. * using antidepressants, except stable drugs maintained for more than three months; * visual impairment, such as cataract, glaucoma, blindness, etc; * cognitive impairment (mmse \< 24); * there are uncontrollable hallucinations and mental diseases; * there are sleep phase delay / advance syndrome, shift work, jet lag, etc
a study comparing two rifaximin tablets in patients with travelers' diarrhea.

Conditions: Travelers' Diarrhea

Summary: this study compared safety and efficacy of a generic rifaximin tablet to the reference listed drug in the treatment of travelers' diarrhea. additionally both the generic and reference formulations were tested for superiority against a placebo tablet. it was planned that 450 patients would be enrolled, but only 28 patients were randomized. of these, 1 patient discontinued due to failure to meet the inclusion/exclusion criteria. the remaining 27 patients received study drug and 25 patients completed the study. the study was terminated due to slow enrolment. the final analysis included only safety analysis in the safety population, due to the low number of randomized patients. no efficacy analysis was performed.


Eligibility criteria:
inclusion criteria: * patient is able to read and understood the language of the informed consent form and patient information. * international travelers with a duration of stay in host country long enough to attend schedules visits. * affected by naturally acquired acute diarrhea, defined as the passage of at least 3 unformed stools within 24 hours immediately preceding randomization preceding randomization exclusion criteria: * hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any of the excipients of the study drug. * pregnant, breast feeding or planning pregnancy * acute diarrhea for \> 72 hours immediately prior to randomization. * presence of fever (≥ 100 °f/37.8°c) or hematochezia (blood in stool, noted visually) or clinical findings suggesting moderate or severe dehydration.

Keywords: travelers diarrhea rifaximin equivalence
emdr intervention for psychological trauma among syrian refugees

Conditions: Psychological Trauma

Summary: to implement an emdr (eye movement desensitization and reprocessing)intervention to treat the trauma symptoms among syrian refugees.

in this project we aim to treat the posttraumatic stress disorder (ptsd) symptoms among syrian refugees through an effective psycho-therapy technique called eye movement desensitization and reprocessing (emdr). randomly selected refugees will be assessed through mini plus for the diagnose of ptsd. eighty refugees with ptsd will be randomly allocated to either 7 sessions emdr or wait-list control group.symptoms of ptsd (mini plus, htq, ies-r) and depression and anxiety (bdi, hscl)will be assessed at pre- and post-treatment and 4 weeks follow-up. however, to our knowledge this is one of the first intervention studies which will be conducted in a refugee camp. therefore we expect to have some practical and logical problems. in order to see the feasibility and efficacy of emdr among syrian refugees, before the main study we aim to run a pilot study with less participants. in the pilot we will assess the posttraumatic stress symptoms with impact of event scale-revised (ies-r) and the depressive symptoms through beck depression inventory (bdi-ii).

Eligibility criteria:
inclusion criteria: * trauma symptoms exclusion criteria: * pregnancy * current or past psychotic disorder * current or past substance abuse or dependence * serious physical illness * active suicidal ideation
optimal timing of intrauterine insemination (iui) when utilizing superovulation combined with gnrh antagonists

Conditions: Infertility

Summary: the timing of iui following ovulation induction has been the subject of many studies and a consensus has developed that a single insemination approximately thirty-six hours after ovulation induction is sufficien. the introduction of gnrh antagonists preventing a premature lh surge and early ovulation has added a new dimension to fertility treatment. it allows greater accuracy in predicting the timing of ovulation and has been shown to be at least as effective, if not more effective, as ovarian stimulation without antagonists. we hypothesize that by utilizing gnrh antagonists we can increase pregnancy rates during iui by timing the iui as close as possible to the moment of ovulation guaranteeing the highest and freshest concentration of motile spermatozoa in the fallopian tube at the time the oocyte is released from the ovary. we therefore propose a randomized open three arm prospective trial utilizing superovulation with gnrh antagonists whereby the iui is timed to take place 36, 42 or 48 hours after ovulation induction.


Eligibility criteria:
inclusion criteria: * women with infertility who are candidates for controlled ovarian stimulation and intrauterine insemination with * ovulatory disorder * male factor * partial mechanical factor * endometriosis * unexplained infertility. exclusion criteria: * known allergy to one or more of the utilized drugs * neither fallopian tube is patent * sperm count less than 1 million total motile sperm of normal morphology during at least two investigations * women who are candidates for mono-ovulation. * failure to receive consent * women with baseline functional cysts (i.e. hormone producing) above 12 mm diameter.

Keywords: infertility intra-uterine insemination ovarian stimulation
masseter muscle activity and post-operative pain in a group of egyptian children treated with hall technique vs modified hall technique

Conditions: Masseter Muscle Activity

Summary: the study aims to evaluate postoperative pain and masseter muscle activity in a group of egyptian children with carious primary molars treated with hall vs modified hall technique (with proximal and occlusal reduction).


Eligibility criteria:
inclusion criteria: * children 5-7 years with carious lower second primary molars * both genders. * systemically and mentally healthy. exclusion criteria: * history of systemic or mental conditions. * special health care needs who require pharmacological management before dental treatment. * acute dental pain or trauma. * extremely uncooperative children who require being treated under general anesthesia.

Keywords: hall technique modified hall technique stainless steel crowns
phacotrabeculectomy with collagen matrix implant (ologen®) versus mitomycin c

Conditions: Glaucoma; Cataract; Wound Heal

Summary: 1. study objective: to assess the efficacy and safety of collagen matrix implant (ologen®; olo) in phacotrabeculectomy and to compare with mitomycin c (mmc) augmented phacotrabeculectomy. 2. study design: the study is designed as a prospective randomized trial. patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study. 3. follow-up: this investigation is including 7 post-operative visits and follow-up within 12 months from the date of surgery. patients should be seen at postoperative days 1, 7, 30, 90, 180, 270 and 360.

* prospective randomized comparative study * patients with cataract and: primary open angle glaucoma (poag) pseudoexfoliation (pex) glaucoma (pexg) * phacotrabeculectomy augmented with olo or mmc * follow-up - 12 months

Eligibility criteria:
inclusion criteria: * cataract * primary open angle glaucoma or pseudoexfoliation glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication exclusion criteria: * difficulty in reading or speaking polish * previous ocular surgery * pregnant and breastfeeding women * angle closure glaucoma * secondary glaucoma except pseudoexfoliation glaucoma * ocular diseases with excessive scarring * allergy to collagen or mitomycin c
the effectiveness of guided imagery on pcl-5 scores in adult women with post-traumatic stress disorder

Conditions: Post Traumatic Stress Disorder PTSD

Summary: post-traumatic stress disorder (ptsd) affects a significant portion of the population, with about 13 million americans diagnosed in 2020. women are twice as likely to have ptsd than men. ptsd will affect 8%, or 8 out of every 100 women, at some stage in their lives. this study will check the effects of guided imagery mindfulness on pcl-5 scores in adult women with ptsd. participants in this study will complete a pcl-5 pre-test and post-test to check ptsd symptoms before and after 6-weeks of mindfulness sessions. each participant will engage in 15-minute sessions of guided imagery mindfulness once a week for 6 weeks. before and after pcl-5 scores will show the effect of guided imagery mindfulness on ptsd symptom severity.

background: post-traumatic stress disorder (ptsd) affects a significant portion of the population, with approximately 13 million americans diagnosed in 2020. women are twice as likely to have ptsd than men. ptsd will affect 8%, or 8 out of every 100 women, at some stage in their lives. purpose: this project aims to investigate the effectiveness of guided imagery, a mindfulness technique, on pcl-5 scores in adult women with ptsd. theoretical framework: the cognitive model of ptsd was developed to explain why some people do not recover after trauma and to identify maintaining factors that can be modified in treatment. this model suggests negative appraisals, disjointed trauma memories, and unhelpful coping strategies maintain ptsd. methods: participants in this qualitative study will complete pre- and post-intervention pcl--5 questionnaires, a validated 20-item structured interview designed to assess ptsd symptoms. they will also engage in 15-minute sessions of guided imagery mindfulness interventions. post-intervention, participants will complete a second pcl-5 questionnaire to evaluate any changes in symptom severity. results: analysis of pcl-5 scores will provide insight into the effect of guided imagery mindfulness interventions on ptsd symptom severity. conclusions: mindfulness has the potential to serve as a viable alternative or supplemental intervention for women diagnosed with ptsd. through exploring the potential benefits of mindfulness-based interventions in managing ptsd symptoms, this study seeks to aid in the advancement of more effective treatment options.

Eligibility criteria:
inclusion criteria: * females * ptsd diagnosis (icd 10: f43.1) * 18 to 99 years old * not pregnant * no suicidal ideations * no homicidal ideations * no audio-visual hallucinations * a mobile device, smart phone, laptop * resident at the residential treatment facility exclusion criteria: * males * under 18 years old * above 99 years old * pregnant women * active suicidal ideation * active homicidal ideation * do not have mobile device * active audio-visual hallucinations

Keywords: guided imagery mindfulness post traumatic stress disorder adult women women stress disorders, post-traumatic
adjuvant chemotherapy in combination with tislelizumab in lymph node-positive esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: esophageal cancer is one of the most common malignancies in china, and esophageal squamous cell carcinoma (escc) is the predominant histological type. surgical resection is still a standard therapeutic approach for patients with resectable escc, but the prognosis is still disappointing. although neoadjuvant chemoradiotherapy plus surgery is currently recommended for patients with locally advanced escc, it is still an infrequently used procedure in china. the efficacy of adjuvant therapy on escc is still controversial. recently, the checkmate 577 trial showed that adjuvant nivolumab therapy could improve dfs for patients with residual disease after neoadjuvant chemoradiotherapy plus surgery. however, no optimal postoperative adjuvant therapy was recommended for patients with escc received upfront surgery. we designed a prospective randomized controlled tial to study whether immunotherapy could be used with chemotherapy after surgery to improve overall survival in these patients. the primary endpoint of the study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.


Eligibility criteria:
inclusion criteria: 1. aged between 18 and 70 years 2. untreated before surgery (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy) 3. histologically documented squamous cell carcinoma of the thoracic esophagus with positive lymph nodes （t1-3n1-3m0） 4. undergoing radical esophagectomy 5. ecog (eastern cooperative oncology group) : 0-1 6. no recurrent disease before adjuvant therapy 7. normal hemodynamic indices before the recruitment 8. able to understand this study and have signed informed consent exclusion criteria: 1. previous or concurrent malignancy 2. interstitial lung disease 3. requiring systemic treatment with either corticosteroids or other immunosuppressive medications 4. known or suspected allergy to chemotherapeutic drugs or tislelizumab 5. active autoimmune disease 6. active hepatitis 7. those whom the investigator considered unsuitable for inclusion

Keywords: esophageal squamous cell carcinoma immunotherapy chemotherapy surgery adjuvant therapy